
Yale CRRIT
@yale_crrit
Researchers from @YaleMed, @YaleSPH, & @YaleLawSch studying the regulation & coverage of medical drugs & device, advancing policies that improve patient health
ID: 798930507383918592
https://medicine.yale.edu/crrit/ 16-11-2016 16:47:31
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NEW JAMA Health Forum Special Communication building on the amicus brief filed by Democracy Forward on behalf of Kushal Kadakia, Joseph Ross, & Reshma Ramachandran on the case challenging FDA's LDT Rule, which has now been vacated & not appealed by U.S. FDA. democracyforward.org/work/laborator…

The U.S. FDA says it will “radically increase efficiency” with AI and embrace “radical transparency.” But as Reshma Ramachandran told The New York Times, agency officials recently kicked off a six-city listening tour—with Pharma CEOs—behind closed doors. Here’s the scoop: nytimes.com/2025/06/10/hea…


These 1–2 month reviews may be dangerously fast—even with a fully staffed FDA. But as Joseph Ross told both @STATNews and Regulatory Affairs Professionals Society, mass layoffs raise real doubts about feasibility. Many key details remain TBD. More via Regulatory Affairs Professionals Society: 🔗 raps.org/news-and-artic…

More on the U.S. FDA’s new Commissioner’s National Priority Voucher (CNPV) program: As InsideHealthPolicy paraphrased CRRIT’s Reshma Ramachandran, the promised speed “raises serious concerns about the safety and efficacy of drugs rushed to market.” Full story: 🔗 insidehealthpolicy.com/inside-drug-pr…

(1/12) New in JAMA Internal Medicine: we assess the performance of U.S. FDA's Breakthrough Devices Program across its first 8 years, with a focus on: ⏲️ Review times 💡Innovation 📊 Evidence CC: Joseph Ross Reshma Ramachandran Harlan Krumholz James Johnston


Surrogate markers are increasingly being used to support U.S. FDA drug approvals instead of measuring clinical outcomes. In a new Federation of American Scientists🔬 memo, Reshma Ramachandran Joshua D. Wallach & Joseph Ross outline how FDA can make transparent & strengthen their evidence. fas.org/publication/va…
